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Reaching Empowerment in Genetic Information Regulation in Israel and Germany

Introduction

Collecting and using genetic information is a rapidly expanding area of research exploring genetic predispositions with the goal of developing genetically optimised therapies (Beskow et al., 2001; Issa, 2002). Genetic information, in contrast to other (predictive) health information, can reveal information not only about a particular, unique individual, but about those who are genetically related to him or her, such as members of a particular family (parents, children, siblings) or an even larger ethnic population.

The social effect is likely to be the creation of a new social inequality and new social polarisation between the genetically advantaged and genetically disadvantaged based on genetic predispositions of particular racial or ethnic groups, e.g. predisposition to sickle cell anaemia, cystic fibrosis and Tay Sachs disease (Murray et al., 2001; Bodenhorn and Lawson, 2003; Gollust et al., 2005; Lemke, 2005; Mannion, 2006). The regulation of genetic information raises challenges for policy makers with respect to the appropriate balance needed between relevant interests, such as private agencies and organisations who have legitimate interest in collecting and sponsoring such expensive genetic information technology, and individuals and communities who share their genetic information (Hubbard and Wald, 1999; Anderlik and Rothstein, 2001; Godard et al., 2003; Gerards and Janssen, 2006; Rouvroy, 2008).

Considering the evolution of this matter from an ethical issue to a policy concern, opens an interesting perspective for empirical testing of policy instruments used by policy makers in the field. Yet to be developed, however, is a comprehensive framework for integrating ethical consideration of public policy issues of relevance to genetic information. Thus, this paper considers ethical concerns in relation to individual and community’ empowerment in the use of genetic information. Empowerment has been widely used by social scientists who have dealt with issues related to minority groups, e.g. women, black people, disabled people (Wallerstein, 1992: 198). It is suggested that, in the case of genetic information, empowerment is manifest in the dilemma between one’s interest in protecting sensitive personal information and the general will to obtain this information, for instance in order to undertake research for the benefit of the society as a whole (Rochefort and Cobb, 1994; Gottweis, 2005).

The focus on empowerment as a key strategic concept to which policy instruments purport to advance, can be viewed from three frames of reference that foster empowerment on personal and community levels, including privacy and confidentiality of genetic test results, avoidance of the misuse of genetic information in employment or insurance and direct financial and wider social benefits-sharing as appropriate responses to current public concern (HUGO, 2000). Drawing on these themes of empowerment, this article critically analyzes Israeli and German policies regarding genetic information. These states share the same difficulty in achieving the balance between the goals of developing genetic databases intended to empower individuals and communities to participate in genetic information research under health-care systems and welfare sectors with increasing budgetary restrictions (Cohen, 2001; Hodge and Harris, 2001). Both states have universal and compulsory health-care systems, spending approximately 10 per cent of GDP on health care; of that, 70 per cent is government expenditure. Payment for services is largely provided by the government and labour unions. In the field of genetic information, databases in both Israel and Germany are currently operated by public institutions, such as university clinics, institutes or departments; however, a substantial proportion of these databases are now privatised (Prainsack, 2007; Simon et al., 2007; Ireni-Saban, 2008). Despite relatively similar healthcare systems and the fact they face similar policy challenges in the field of genetic information, Israel and Germany represent distinct national systems of regulation for genetic information.

Subsequent analysis is divided into two sections. The first sets out the main theoretical concept used in this research—policy instruments—in order to explain briefly the key notions used for the comparative analysis of the empirical findings. The second compares the evolution of the regulatory frameworks for the use of genetic information in Germany and Israel, exposing the strengths and weaknesses of the policy instruments utilised in each setting.

Classification of Policy Instruments

This section presents the classification of policy instruments by which governments attempt to put policies into effect. Within the genetic information policy discourse, these must be the regulatory instruments suitable for achieving the aim of adequate protection of individual and community interests without overly affecting other relevant interests, such as valid industry and business interests.

A policy instrument is often defined as a technique or a set of techniques by which governments effect a change of behaviour in a certain direction (Salamon and Lund, 1989; Howlett, 1991; Daugbjerg, 1998; Vedung, 1998). In political science, the concept of a policy instrument has been used to explain the choice within a national political context based on the distinction between public or state and private or voluntary provision of goods and services (Howlett, 1991; Howlett and Ramesh, 1993; Daugbjerg, 1998; Bemelmans-Videc, 1998). This contrasts with the economic stream of literature in which the choice of policy instrument is a technical exercise, where the most effective and efficient instrument for the correction of market failures is identified (Stavins, 1990; Stavins and Grumbly, 1993; Sterner, 2003).

The central assumption of the political science approach to policy instrument choice is that the decision process and its outcomes are shaped by political factors related to the capacity of the state to keep a primary, overarching role in governing processes. The maintenance of state capacity, despite the rapid changes associated with globalisation pressures, according to Pierre and Guy, is ‘because the state, despite persistent rumours to the contrary, remains the key political actor in society and the predominant expression of collective interests’ (2000: 25).

Scholars have made numerous attempts to identify the variety of policy instruments used by policy-makers and to classify them into meaningful categories (Kirschen et al., 1964; Hood, 1986; McDonnell and Elmore, 1987; Schneider and Ingram, 1997; Doern and Phidd, 1992; Salamon, 2002). Howlett and Ramesh (1993) developed a classification of policy instruments by arranging them along the level of state involvement. They offered a voluntary-compulsory continuum along which policy instruments can be ordered. At one extreme of the spectrum are instruments totally devoid of state involvement and at the other extreme are compulsory instruments totally devoid of private discretion. Between the two extremes lies a range of instruments involving varying levels of state and private provisions.

Within the wide variety of policy instruments, four instruments are usually proposed for different degrees of government intervention with respect to genetic information policy making. These include: constitutional provisions that contain fundamental privacy protection rights and basic principles of the institutional system; statutory legislation, where individual states enact legislation in an attempt to restrict the use of genetic information by private actors; industry self-regulation, which occurs where a collective group, industry or profession is required to formulate and enforce norms within a government framework without any active intervention from the state; and moratoria, which is identified as a voluntary practice affording the industry time to formulate an alternative policy strategy while studying the consequences of the use of genetic information and testing on health and medical research.

Having defined the concept of a policy instrument in a general way, it is necessary to distinguish a number of dimensions that can explain policy instrument choice in order to make the concept fruitful as a tool for comparative policy analysis (Bemelmans-Videc, 1998; Rist, 1998; Howlett, 2005; Howlett et al., 2005). Major dimensions of policy instrument choice include degree of coercion, targeting, past experiences, political support/opposition and ideological preferences (Linder and Peters, 1989; Howlett, 1991; Howlett and Ramesh, 1993). The operational definitions of these dimensions are as follows:

Coercion refers to the dominant role of the state in decision making, consciously working to exclude organised interests from policy making; in other words, the extent of organisational ability to affect societal actors.

Targeting is identified by clarification and precision of the problem situation.

Political context includes political culture, pattern of social conflicts, the nature of support and opposition, accountability and past experience.

Ideological preferences or principles limiting or advancing government intervention in industry. A focus on these factors related to state capacity helps to explain why these national styles of instrument choice exist.

As to empirical analysis of the German and Israeli cases, our approach is based on a comparative analysis of policy instruments. We examine the appropriateness of various policy instrument choices made in Israel and in Germany for securing the rights for privacy, non-discrimination and access to research benefits for individuals and communities. The article is based on a literature study of public documents, such as governmental bills, proposals, statements and consultation responses.

Genetic Information and Privacy Protection

The use of genetic information invokes academic and legal debate on the need to introduce specific genetic information legislation and protect genetic privacy (Lemmens, 1999; Anderlik and Rothstein, 2001; Suter, 2001). Some legislators and policy officials believe that parts of the existing medical information privacy laws are broad enough to encompass protection of genetic information, while others claim that the use of genetic information challenges a number of existing legal tools, such as intellectual property, privacy and informed consent in private-funding research.

The Israeli government preferred to use a coercive instrument to respond to the concerns about commercial use of genetic information. In fact, the special nature of DNA and genetic information with respect to individual rights has been recognised in a law on genetic information, adopted in Israel in 2000. The Genetic Information Bill supported by M. K. Meir Shetrit (Likud, a right-wing party) in 1998 sought to create legal protection for the rights of individuals with respect to their DNA samples and the genetic information derived from them. Ideologically, Likud has traditionally supported economic liberalisation. However, there are also statist elements within the party, and therefore more recently it has been difficult to distinguish between this party and Labour on such issues, particularly since Labour has abandoned most of its socialist past (although its traditional links to the unions have made it more reluctant at times to back radical reforms in some areas). Nevertheless, both parties broadly advocate less government intervention in the economy and have pursued—albeit unsteadily—privatisation and fiscal and monetary stability. Therefore, it is somewhat surprising that the government chose a coercive instrument aimed directly at private actors in a small country such as Israel where the biotechnology industry does not yet have the scope to master worldwide markets. It seems that government choice in this regard may be influenced by the prominent role of ethnic cleavages. The close correlation between ethnicity and socioeconomic class in Israel remains the main axis along which the Ashkenazi-Oriental cleavage is drawn. The ‘hardening’ of ethnicity into social class—what some analysts have referred to as the formation of Israeli ‘ethnoclasses’—represents, with the Orthodox-secular division, the most serious cleavage dividing the Jewish society of Israel from within (Hazan and Maor, 2000).

An example of such political pressure is the Ethiopian blood scandal. During 1996, the blood donated by Ethiopians was being discarded by blood banks on suspicion that some of it may have been contaminated by the HIV virus. According to Israeli officials, this was likely to result in a general reluctance to participate in genetic research programs—particularly if a credible and secure system of personal data protection cannot be demonstrated to the Israeli public (Derfner, 1996). Hence, the Israeli government responded to this social unrest by broadly welcoming the National Committee of Research and Development guidelines of privacy protection in genetic data testing and handling in statutory legislation. The law places controls on the way in which personal information is collected and retained, and prevents the disclosure of personal information to third parties without the consent of the individuals concerned. As a general rule, all samples should be anonymised before analytical research on human genes is conducted in order to protect and maintain the privacy of the participants.

A further effort toward privacy rights was considered by the Ethics Bureau of the Israel Medical Association, headed by Prof. Avinoam Reches in 2003. The committee issued a report on the way researchers should work with community representatives to obtain collective informed consent for predictive genetic testing, stating that information such as the following should be included:

The purpose of the test;

A description of the testing process;

The accuracy of the genetic test and the meaning of its results;

The risks and benefits of, and alternatives to, genetic testing;

Confidentiality issues including how specimens are stored and used for research.

It is claimed that the Genetic Information Law of 2000 indicated a communitarian approach in addressing the issues of genetic testing, setting boundaries within which personal autonomy was to be exercised. The specific responsibilities and goals set out in the new state legislation provided an inter-relationship of individual values, rights and needs with communal values, civic duties and public welfare.

The German genetic information policy is significantly less coercive than that in Israel. At the constitutional level, the protection of human dignity is enshrined in Article 1(1) of the German Constitution (The Basic Law). Participants’ rights in large-scale genetic research of self-determination with regard to their bodies, their bodily substances and their personal data are protected in the form of the right-to-life and physical inviolability (sentence 1 of Article 2(2) of the Basic Law) and the general rights of personality (Article 2(1) with Article 12(1). of the Basic Law). However, with no specific privacy protection of genetic information, the countervailing principles are those of the freedom of science and research (sentence 1 of Article 5(3) of the Basic Law) and free choice of profession for research workers (sentence 1 of Article 12(1). of the Basic Law). Thus, framing constitutional legislation in terms of ‘general rights’ rather than ‘general good’ proves that civil law is aware of the direct and immediate harm to social interests, but overlooks the value of social responsibility when the harm to social interests is indirect, cumulative and long-term, as in the case of genetic discrimination.

Criticism on the lack of state legislation of genetic information policy was raised in a report of Technology Assessment of Genetic Testing published in December 2000 by the Office of Technology Assessment of the German Parliament (TAB). (Gesamtverband der Deutschen Versicherungswirtschaft). The report called for government responsibility to impose controls and limit market mechanisms. However, this criticism has not yet emerged in statutory regulation and the responsibility to design genetic information policy was left to non-governmental actors, such as commercial and biotechnology companies. These actors, with their business strategies, showed a growing interest in becoming involved in the deliberation processes about sector policies. This gave rise to voluntary initiatives by the industry in 2001 to achieve privacy protection in genetic testing. The German insurance industry offered a five-year moratorium on the use of genetic test results. This commits German insurance companies to not use predictive genetic tests for insurance purposes, except for expensive policies. They have also agreed not to ask for disclosure of the use of genetic tests previously carried out for some other purpose. For large policies, German insurers may ask for the disclosure of an existing test.

It seems that self-imposed restrictions set by the insurance industry can be expressed as a blocked transaction within the free market sphere. The meaning of self-imposed regulation by private insurance companies is that the state actually authorised the German insurance companies to compel policy action from a privileged power position. This process led to the formulation of regulations on the use of genetic information in the interests of economic efficiency rather than social welfare. It indicates the growing influence of the liberal view of the role of the state. Thus, the German insurance companies became the main actors responsible for determining the extent of privacy and confidentiality that individuals will be afforded, encompassing access to both personal information and data, and to tissue samples as carriers of information, while avoiding accountability through the conventional policy process.

Non-Discrimination Policy in Insurance and Employment

A further important factor that may discourage individual and/or community participation in genetic research is the fear of genetic discrimination in employment and insurance. Employers may make selective hiring, placement, promotion or termination decisions based on genetic profiling. Insurance companies may discriminate against asymptomatic or pre-symptomatic individuals when assessing eligibility and setting insurance premiums (Billings et al., 1992; Natowicz et al., 1992; Alper et al., 1994; Hall and Rich, 2000; Lemke, 2005).

The central importance of protecting individuals and communities from discrimination is enshrined in sections 29 and 30 of Genetic Information Law 5761-2000 of Israel, which states that: ‘An employer shall not require an employee or a person applying for employment (in this section—an employee) to provide genetic information or to undergo genetic testing … An insurer shall not ask an insured or a person applying for insurance (hereinafter—an insured) whether such person has undergone genetic testing and shall not ask for the results of genetic testing from an insured, nor request such person to undergo genetic testing.’ The report of the Israel Academy Bioethics Committee backed the law guidelines with the threat of legal sanctions, emphasising the concern of group genetic discrimination in research: ‘Genetic profiling of a collectivity that can be defined by ethnic or national origins could lead to risks of stigmatisation of all those who belong to the collective. Worse, this could lead to discrimination in various forms—moral, physical or economic.’

The government choice to introduce statutory legislation rather than voluntary regulatory measures could be partly explained by the Jewish historical experience of racial discrimination and stigmatisation. The fear of Jewish stigmatisation was recently raised by the Ashkenazi Jewish community in the US over genetic screening programmes. During that time, the American Jews called on the National Human Genome Research Institute (NHGRI) to set ethical guidelines to secure their community (Ashkenazi Jews) from genetic discrimination by health insurance companies. According to Marlene Post, president of Hadassah, the Jewish women’s organisation that sponsored the meeting with the Jewish Council for Public Affairs, all participants shared a concern of fear of discrimination and stigmatisation. ‘We need to protect ourselves both from discrimination and ignorance … We’ve got to start breaking down myths that ethnic groups mean genetic groups. They don’t’ (Wadman, 1998:851).

In 2005, the German parliament debated a proposed anti-discrimination law put forward by the government. Based on a series of EU directives, the anti-discrimination law would make punishable discrimination based on race, ethnic origin, age, sex, disability or sexual orientation. The primary aim of the law is to prevent discriminatory practices in the workplace, in educational institutions or, for example, by landlords. Until the new law, workers in Germany relied on the country’s general dismissal protection. The opposition to the law includes industry and trade groups, who accuse the governing coalition of Social Democrats and Greens of trying to create more bureaucracy and tight regulatory measures that could hinder economic growth. Nevertheless, the new Anti-Discrimination law does not address genetic discrimination by employers or insurance companies. However, the existing law, which is designed to prohibit discrimination in employment based on certain disability characteristics that may be linked to genetic traits, could provide protection against genetic discrimination in some cases. The need for targeting and coercive legislation to address existing problems posed by genetic testing techniques can be demonstrated in the case of a German teacher’s genetic discrimination suit in October 2003. A young teacher in Germany was refused a permanent job on the grounds that members of her family had Huntington’s disease and she was, therefore, at risk of developing the disease herself (Burgermeister, 2003; Darmstadt Administrative Court, 2004; Lemke, 2005). Under German employment law, government authorities can reject candidates for civil service, including teachers, on the grounds of ill health to minimise absenteeism and save money. The applicant lodged an appeal against this decision before the Administrative Court in Darmstadt, which ruled mainly in her favour and instructed the State of Hessen to immediately appoint her to government service. In the court’s opinion, the school authorities had wrongly assessed the state of her health as an applicant. The school board declined to contest the decision and has since employed the woman in question under a government service contract. Thus, this case raised concerns that employers could use the current legal vacuum on genetic testing in Germany to discriminate unfairly against employees.

The German example has shown that introduction of statutory legislation may be favoured over constitutional regulative instruments since the greatest threat of infringements is not caused by private parties, such as employers and private insurers, but by state authorities.

Governing Benefit Sharing

With the rapid development of high-throughput technologies allowing for the screening of very large numbers of samples, and with growing recognition of the important role genetic variation can play, there has been a tendency to try to generate large national population collections in various countries (Iceland, Estonia, Latvia, Sweden and the UK, for example), or to investigate sub-populations with defined characteristics (in Italy and Finland, for instance). Regulating benefit sharing from genetic information databases needs to provide participants access to the benefits, which might include profit sharing, information, better medicines and treatments, improved access to health care and funding for continued studies, or additional research on concerns identified by the community.

In Israel, one of the challenging regulatory issues was the management of DNA sample collections from Ashkenazi Jews by the Israeli commercial company IDgene Pharmaceuticals Ltd. IDgene is a privately owned population genomics company focused on identifying the genetic basis of common diseases. The commercial interest of IDgene in the use of genetic information raised public concerns over the regulation of large population-based genetic studies.

Genetic information, as explained above, constitutes an important instrument for genetic research. Positive results will bring benefits not only to the donor and his/her family, but also to the entire human community. This ‘advantage for the collective’ is an important concept underlined in two reports. The first was issued by the Bioethics Advisory Committee of the National Academy of Sciences, headed by Prof. Michael Ravel. The second was issued by the Ethics Bureau of the Israel Medical Association, headed by Prof. Avinoam Reches (Reches, 2002). Both reports stated that not only should researchers work towards applying their results towards the common good, but whenever research uses samples of biological material it is generally assumed that the donor offers the sample for the benefit of the community rather than for personal profit or for the exclusive profit of a private company. There exists a fundamental communitarian ethics principle that ‘donated’ biological material should not become a good of solely economic concern, but that the return of benefits to the community must be guaranteed. Indeed, Prof. Kasher, one of the committee’s members argued that the collective notion of ownership (e.g. of research results or human tissue). needs to be clarified, and that ownership of data should be defined to include the communities providing the data, as well as the researchers studying the data (Reches, 2002)

In the case of benefit sharing, the Israeli government seems to prefer to leave some room for interpretation, yet still include communitarian criteria to make clear under what conditions the use of genetic information is allowed. As such interpretation has not yet emerged in statutory regulation, the regulation of benefit sharing in genetic information research tends to be reflexive and less targeting and coercive.

In Germany, the concern for benefit sharing was raised in the German National Ethics Council (Nationaler Ethikrat) in 2004, debating the regulation of biobanks for research.9 It was suggested that since most genetic databases in Germany are initially used for fundamental research, this does not as a rule generate a financial return. The council then concluded that compulsory measures to gain acceptance from commercial companies regarding financial returns are needed, since this balancing of private gain with public benefit would compete with the taxation system. The fact that the council’s recommendations did not emerge as a compulsory regulation reveals that once liberalisation had taken place in this policy sector, we find that the governmental actors remain in a secondary position, while companies such as the pharmaceutical industry effectively gain a certain level of influence in genetic information policy making.

Summing Up

The comparative analysis has shown that the regulatory measures of balancing public and private interests in genetic information research may be different in similar health-care systems. In evaluating policy instruments that provide solutions to the problems posed by the use and acquisition of genetic information, it is suggested that Germany and Israel have little consensus on the proper level of regulation.

Indeed, in the areas of privacy protection and non-discrimination policy, the Israeli government preferred to use coercive instruments to respond to concerns about commercial use of genetic information. The Genetic Information Law 5761-2000 of Israel creates legal certainty and clarity based on communitarian interpretation of individual and community genetic information. It is argued that the Israeli state appears to include non-discrimination and privacy protection specific to genetic information mainly because of the Jewish past experience with racial discrimination and stigmatisation, and by the prominent role of ethnic cleavages in Israeli society. These experiences have increased the awareness of the danger of abuse, resulting in a strong call for special protection and coercive regulation. In contrast, the state of genetic regulation in Germany relies on constitutional arrangements encouraging existing self-imposed restrictions by the private actors. The provisions mentioned in the German constitutional law are broad enough to encompass protection of genetic information, but have not yet been interpreted into practicable and enforceable genetic privacy and non-discrimination protection. It seems that the German government is more desirous of introducing constitutional provisions for privacy protection that are formulated in a broad and flexible way so as to have a politically desirable liberal effect, namely to support and advance commercial and economic interests to legitimise the public interests in collecting and using such information for developing German industry.

In the area of benefit sharing policy, both Israel and Germany choose to avoid utilisation of a coercive instrument formulated in well-described standards that might be problematic in a competitive area such as that of genetic research. Thus, the regulation of benefit sharing in collecting and using genetic information has so far exclusively been left to self-regulation by the market. It seems that use of voluntary regulatory measures reflects a liberal view, because the benefit sharing objective has not yet raised any public concerns that would warrant disproportionate state intervention.

Conclusions: The Implications for Genetic Information Policy Making

The entry of genetic information on to regulatory agendas across the globe calls for engagement with ethical concerns for policy makers who do not generally see ethical debate as their primary interest. This paper illustrates that although policy instrument classification may not be able to predict policy outcomes for scholars, it can be used as a strategic tool for policy makers and civil society organisations that wish to develop a comprehensive understanding of the context in which they work and the options for pursuing their strategic objectives.

The comparative analysis of Israeli and German regulation of genetic information supports the claim that statutory legislation, rather than self-regulation, provides a more appropriate means to reconcile the various conflicting interests in terms of individual and community empowerment. Indeed, self-regulation cannot provide systematic governmental evaluation of how well ethical guidelines or codes of conduct fare in practice, or any substantial evidence of the extent to which they are adopted and implemented. In cases of genetic privacy and discrimination, for example, wrongdoers may not be as effectively sanctioned as they might otherwise be if these ethical norms do not have the force of law behind them. Moreover, in the case of benefit sharing, this paper raises the need to address the issue of ownership (e.g., of research results or human tissues) in statutory legislation in order to prevent the public from losing faith in the promises of genetic information research. Thus, in order to justify voluntary public participation in genetic information databases, this paper suggests treating genetic information as distinct from other types of health information. It suggests educating, informing and seeking the consent of participants at all stages of the genetic information research; sensitising researchers to the risks of stereotyping and stigmatisation based on ethnic origin and recognising and respecting ethnic and cultural sensitivities; requiring researchers to provide research benefits and encouraging multidisciplinary research teams that include both biomedical and social scientists.

It is argued that, in the future, National Bioethics Advisory committees in Israel will take a leading role in shaping genetic information policy making. The fact that these committees’ members are coming from different disciplines—ethics, law, science, religion, etc.—promotes dialogue with the public about the ethical, legal and social implications of genetics research. These committees are instrumental for regulation since they provide a forum favourable to the development of a common view among various actors on genetic information policy making. Hence, statutory legislation based on bioethics committee guidelines will continue to have a relatively strong effect in Israel, justifying individual and community voluntary participation in research on the one hand and commercial investment on the other, for the sake of society’s welfare as a whole. Indeed, growing public involvement in the meetings and deliberations of the National Bioethics Advisory Commission and the broad dissemination of the Commission’s reports to researchers and the public explain why the government accepts the role of bioethics commissions to set out coercive policy instruments in the area of genetic information. In the German case, it seems that the entry of a coercive counterbalancing power, such as the EU, into the regulation of genetic information in Germany may lead towards tight and coercive regulation of genetic information.